Lateral Ridge Augmentation Using Two Graft Combination and a Cross-linked Collagen Membrane

NCT06523686 | Completed Phase 2

• 1 other identifier: USJ-2023-57
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. Various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (2)

• Linear bone width changes

  Linear bone width changes assessed clinically and radiographically in mm

  6 months

• Volumetric bone changes

  Volumetric bone changes assessed radiographically in cubic mm

  6 months

Secondary Outcomes (2)

• Clinical Ridge Height gain

  6 months

• Probe penetration

  6 months

Study Arms (2)

Allogeneic-xenogeneic combination

EXPERIMENTAL

A mix of 2/3 allogeneic bone with 1/3 xenogeneic bone

Procedure: Guided bone regeneration

Autogenous-xenogeneic combination

EXPERIMENTAL

A mix of 2/3 autogenous bone and 1/3 xenogeneic bone

Procedure: Guided bone regeneration

Interventions

Guided bone regeneration PROCEDURE

Compare the linear and volumetric bone width changes, clinically and radiographically, between two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal GBR.

Allogeneic-xenogeneic combination; Autogenous-xenogeneic combination

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients, non-smokers or smokers \<10 cigarettes/day.
• Age between 20 and 75.
• Full mouth bleeding score (FmBS) \<20 %.
• Full mouth plaque score (FmPS) \<15%.
• Residual bone width \< 5 mm and adequate bone height in the maxilla and the mandible.
• Tooth extraction performed at least 6 weeks before surgery.
• Presence of enough teeth to support an occlusal stent/radiographic guide.

You may not qualify if:

• Systemic diseases.
• Heavy smokers (\> 10 cigarettes/day).
• History of radiotherapy in the head and neck region in the last 5 years.
• Active periodontitis on the remaining teeth.
• Pregnancy.
• Intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin D and metabolites at therapeutic levels within the last 6 months).

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph university

Beirut, 00000, Lebanon

Location

Study Officials

• Celine Rassi, DDS

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontology resident

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 26, 2024
• Study Start: January 9, 2023
• Primary Completion: June 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)